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ABIO33/18. Multicenter, randomized, open-label clinical study on the performance and safety of ABIO 33/18 (cross-linked hyaluronic acid gel with sodium clodronate) compared to Monovisc®️ after intra-articular injection in subjects with osteoarthritis (OA) of the knee.

Project objectives

Primary objective:

The primary objective of the study is to evaluate the non-inferiority of ABIO 33/18 ia compared to Monovisc®️ ia, in terms of reduction of joint pain at rest in the target knee, on the 90th day (control visit), reduction of joint pain at rest in the target knee, on day 90 (visit 6), measured by VAS (0-100 mm) in subjects with knee osteoarthritis.

Secondary performance objectives:

- Assess pain at rest in the target knee, assessed by VAS, at all other visits;

- Evaluate the relapse time;

- Assess improvement in symptom severity and functional status by assessing changes in the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) on a Likert scale;

- Compare the Patient's Global Performance Rating using a 5-point scale;

- Compare the clinician's global performance rating using a 5-point scale;

- Evaluation of the 5-level version of the EuroQol 5-dimension (EQ-5D-5L) (questionnaire + VAS) quality of life index;

- Evaluate the Knee Injury and Osteoarthritis Outcome Score (KOOS);

- Evaluate the consumption of concomitant analgesics in terms of percentage of subjects, duration (days) and daily dose;

- Evaluate the usability of ABIO 33/18.

Security objectives:

- Evaluate safety (in terms of adverse events) and tolerability (blood parameters and physical examinations).

Start and end date

May 2023 - Ongoing

Project Manager

Prof. Rocco Papalia – Director of Orthopedics and Traumatology
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